Common Sense for Drug Policy Blog

OCTOBER 29, 2024

Limited Evidence for Nalfmefene "In 2021, due to the widespread availability of high-potency synthetic opioids like fentanyl, the US FDA approved two high-dose naloxone products, an 8 mg IN spray (Kloxxado) and a 5 mg IM injectable (Zimhi). mg IM vs. 8 mg IN and 2 mg IM vs. 5 mg IM, respectively). In 2023, the FDA approved a 2.7

FDA Approval 52

FDA Approval Pharmacokinetics Packaging FDA 52

Drug Patent Watch

DECEMBER 30, 2024

Key Requirements for Generic Drug Approval Bioequivalence Studies : The PMDA requires bioequivalence studies to ensure that the generic drug is equivalent to the RLD in terms of its pharmacokinetic and pharmacodynamic properties. Conclusion The regulatory environment in Japan for generic drug development is complex and evolving.

Drug Development 52

Drug Development Clinical Pharmacology Clinical Trials Pharmaceutical Companies 52

Conversations in Drug Development Trends

JANUARY 21, 2025

Bioanalysis during clinical development of a drug is an indispensable process where trials obtain critical data pertinent to pharmacokinetics (PK) and pharmacodynamics (PD) and as readouts that are crucial for assessing the safety and efficacy of the drugs.

Clinical Trials 78

Clinical Trials Laboratories Trials Drug Development 78

New Drug Approvals

MAY 9, 2025

1] [8] Pharmacokinetics Elacestrant has an oral bioavailability of approximately 10%. [1] Jump up to: a b “Orserdu Product information” Union Register of medicinal products. 1] Additionally, elacestrant is a selective estrogen receptor degrader (SERD), meaning it induces the degradation of ER. [1] 18 September 2023.

FDA 62

FDA Pharmacokinetics Therapies Treatment 62

FDA Law Blog: Biosimilars

JULY 23, 2024

Lenz, Principal Medical Device Regulation Expert — For several years, FDA has requested that sponsors of drug or biologic led combination products identify essential performance requirements (EPRs) related to the device constituent in their applications. By Adrienne R. does not use this term.

FDA 105

FDA Drugs Pharmacokinetics Production 105

Drug Target Review

JUNE 6, 2025

And in the small molecule space, it’s about overcoming pharmacokinetic factors and formulation issues.” Greally explains that this iterative approach allows for more rigorous evaluation of ADC candidates, particularly in relation to pharmacokinetics and in vivo performance.

Small Molecule 52

Small Molecule Pharmacokinetics Packaging Drugs 52

Chemical Biology and Drug Design

JANUARY 29, 2024

In first method, catalytic amidation was carried out under microwave irradiation using Ceric Ammonium Nitrate (CAN) as a green catalyst where as in second conventional method; CDI was used as a significant coupling reagent to optimize reaction condition and yield of product. The results showed slight toxic nature of new compounds.

Pharmacokinetics 100

Pharmacokinetics Production Drugs Research 100

ASPET

SEPTEMBER 16, 2024

We further demonstrate that daily oral treatment with a novel mitofusin activator derived from the natural product piperine can reverse these neurological phenotypes. Here, we describe motor and sensory neuron dysfunction characteristic of clinical CMT type 2A in a CRISPR/Casp-engineered Mfn2 Thr105Met (T105M) mutant knock-in mouse.

Small Molecule 100

Small Molecule Pharmacokinetics Engineering Disease 100

Chemical Biology and Drug Design

MARCH 6, 2024

Abstract Targeting pro-inflammatory cytokines and their production is found to be of therapeutic benefit for the regulation of inflammation in various chronic autoimmune diseases. cell lines along with the testing of nitrite production effect (Griess assay) and cytotoxicity (MTT) analysis.

Pharmacokinetics 100

Pharmacokinetics Regulations Disease Production 100

The Pharma Data

NOVEMBER 17, 2020

The study demonstrated favorable proof-of-concept for LYT-100’s tolerability and pharmacokinetic (PK) profile, which will also enable twice-a-day (BID) dosing of LYT-100 in future studies. LYT-100 is PureTech’s most advanced wholly-owned product candidate. About LYT-100.

Pharmacokinetics 52

Pharmacokinetics Treatment Trials Production 52

Alta Sciences

AUGUST 7, 2023

[NEW EBOOK] Safety Assessment for Ophthalmic Products tchichekian Mon, 08/07/2023 - 19:08 HTML Excellence in Ophthalmic Safety Testing Altasciences has been conducting ophthalmic safety testing for decades, with all global regulatory submissions from our studies approved for design, conduct, and data integrity.

Production 40

Production Pharmacokinetics Drug Development Drugs 40

The Pharma Data

JUNE 25, 2025

The company announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific advisory body of the European Medicines Agency (EMA), has issued a positive opinion recommending approval of a new tablet formulation of BRUKINSA for all currently approved indications. Alignment with U.S.

Packaging 52

Packaging Pharmacokinetics Marketing Therapies 52

The Pharma Data

JUNE 25, 2025

The goal is to boost SMN protein production more effectively and offer a more convenient, once-a-year dosing schedule , thereby improving long-term disease management and patient compliance. The study included two parts: Part A : A randomized, placebo-controlled segment in healthy adult male volunteers.

Therapies 52

Therapies Trials RNA Treatment 52

Drug Patent Watch

JANUARY 14, 2025

The Thyroid Association’s Concerns The American Thyroid Association (ATA) had raised concerns about the FDA’s methods for determining bioequivalence between levothyroxine products[2]. They recommended avoiding switching between levothyroxine products, leading to a preference for brand-name prescriptions.

Drug Development 67

Drug Development Drugs FDA Production 67

New Drug Approvals

JUNE 11, 2025

Substitution of 2-(piperazin-1-yl)pyrimidine ( GEPI-001 ) with 1,4-dibromobutane ( GEPI-002 ), followed by ring opening and addition, generated the final product Gepirone. An efficient approach of Gepirone has been disclosed in Scheme 11 [41]. A further approach for the synthesis of gepirone is described in the literature (Ί).

FDA 62

FDA FDA Approval Treatment Clinical Trials 62

DrugBank

SEPTEMBER 19, 2024

However, translating a promising therapeutic candidate into a successful oral medication presents pharmacokinetic and pharmacodynamic challenges.    Pharmacokinetics of Oral Drugs  Orally administered drugs undergo a series of biochemical processes that can affect their bioavailability and their clinical efficacy.

Drugs 98

Drugs Pharmacokinetics Treatment Disease 98

The Premier Consulting Blog

MAY 31, 2023

While the type, number, and design of these studies vary based on product-specific characteristics, IND-enabling packages submitted to the FDA generally include key information about the pharmacology, pharmacokinetics, and toxicology of the product. All these studies need to be performed under GLP.

Packaging 52

Packaging Pharmacokinetics Small Molecule Clinical Trials 52

Drug Target Review

NOVEMBER 1, 2023

ATX is mainly involved in phospholipidic metabolism and the production of extracellular lysophosphatidic acid (LPA) from lysophosphatidylcholine (LPC). Autotaxin has lysophospholipase D activity leading to tumor cell growth and motility by lysophosphatidic acid production. Cancer Metastasis Rev. 2018 Sep;37(2–3):509–18.

Clinical Trials 134

Clinical Trials Trials Small Molecule Disease 134

Drug Target Review

JUNE 19, 2025

It produces a harmful by-product, NAPQI, which can cause serious hepatic and renal damage. South Rampart Pharma has completed its Phase 1 clinical trial, demonstrating strong safety, tolerability and pharmacokinetics. Liver-safe by design One of the long-standing issues with paracetamol is its liver toxicity.

Clinical Trials 52

Clinical Trials Molecular Biology Treatment Trials 52

thought leadership

DECEMBER 10, 2024

The pharmacokinetic (PK) principles of this guideline are generally applicable to other orally and non-orally administered drug products in which reliance on systemic exposure measures is suitable for establishing BE, e.g., certain rectal, inhalation, and nasal drug products.

FDA 52

FDA Pharmacokinetics Production Drugs 52

The Pharma Data

JUNE 11, 2025

Conducted in healthy adult volunteers, these studies were designed to evaluate the pharmacokinetics and establish bioequivalence between the new tablet and the original capsule form. This move is in line with BeOne’s global commercialization strategy, which emphasizes product accessibility and regional adaptability. Source link

FDA Approval 40

FDA Approval FDA Treatment Therapies 40

biobide

SEPTEMBER 29, 2023

Nowadays, the development of informatic models and the advances in Artificial Intelligence (AI) allow accurate predictions on complex biological processes such as pharmacokinetics or vast screenings of Drug candidates, based on the prediction of their pharmacological effects.

Animal Testing 106

Animal Testing Drugs Pharmacokinetics Regulations 106

Drug Target Review

OCTOBER 24, 2023

Live Bacterial Products (LBPs) will provide patients with a desirable, credible, safe and effective treatment option. Microbiotica, a pioneering company that has developed a Discovery Platform that has paved the way for the creation of Live Bacterial Products (LBPs).

Treatment 122

Treatment Pharmaceuticals Pharmacokinetics Production 122

Drug Target Review

DECEMBER 11, 2024

Purity and radioactive enrichment are key factors in ensuring the IS aligns with product specifications. For these studies, a comprehensive approach to drug metabolism and pharmacokinetics (DMPK), along with immunogenicity is essential, drawing on expertise from multiple disciplines.

International 52

International Laboratories Drugs Pharmacokinetics 52

New Drug Approvals

OCTOBER 12, 2024

The product slowly crystallized. Clinical Pharmacokinetics and Safety of ALZ-801, a Novel Prodrug of Tramiprosate in Development for the Treatment of Alzheimer’s Disease. Clin Pharmacokinet. The mixture was stirred at reflux for 1 h, and then cooled to room temperature. The solid material was collected by filtration.

Pharmacokinetics 62

Pharmacokinetics Small Molecule Disease Licensing 62

The Premier Consulting Blog

JULY 31, 2024

Regulatory Pathway 505(b)(2) versus 505(b)(1) In the US, novel new small molecule drug products, including some peptides, are regulated, and approved by the FDA under the Federal Food, Drug, and Cosmetic Act (the “Federal FD&C Act”) under two key regulatory pathways: Section 505(b)(1) and Section 505(b)(2) NDAs.

Clinical Pharmacology 52

Clinical Pharmacology Drug Development Pharmacokinetics Drugs 52

Drug Target Review

APRIL 22, 2024

Despite excellent pharmacokinetic and stable antibody-linker connections, such ADCs have yet to receive market approval. How do the selection of linkers and conjugation sites impact the pharmacokinetics and therapeutic window of an ADC?

Pharmacokinetics 75

Pharmacokinetics Drugs Organic Chemistry Engineering 75

DrugBank

MARCH 7, 2024

Pfizer, for instance, is eyeing a significant share of this space, working on an oral GLP-1R agonist, Danuglipron, with the intention to introduce a once-a-day version of its weight management product. However, challenges related to tolerability remain a concern, prompting analysts to question the viability of Pfizer’s strategy.

Pharmaceutical Companies 98

Pharmaceutical Companies Pharmaceuticals Clinical Trials Therapies 98

The Premier Consulting Blog

AUGUST 8, 2024

On July 31, 2024, the US Food and Drug Administration (FDA) announced Fiscal Year 2025 (FY2025) Prescription Drug User Fee Amendments of 2022 (PDUFA VII) fee rates for the review of human drug and biological product applications along with prescription drug program fees. patients with renal, hepatic, or cardiovascular concerns).

Drugs 52

Drugs Pharmacokinetics FDA Production 52

Drug Target Review

JUNE 16, 2025

Unlike traditional pharmacokinetic (PK) studies that rely on plasma measurements alone, MSI, when combined with traditional histology, enables spatial mapping of drug distribution, metabolism and target engagement. His graduate research focused on the structural characterisation and synthesis of marine natural products.

Drugs 52

Drugs Organic Chemistry Laboratories Pharmaceuticals 52

PPD

JULY 29, 2024

AI can also predict the likelihood of a serious adverse event before administering the investigational product at an individual level, allowing patients to be categorized by their risk profile. AI has the capability to analyze and forecast the pharmacokinetic (PK) profiles of drugs following their administration.

Clinical Research 98

Clinical Research Clinical Trials Research Trials 98

The Pharma Data

DECEMBER 17, 2020

Previous technologies have been constrained by dose-limiting toxicities, poor pharmacokinetic profiles, and attenuated efficacy. Janux’s proprietary TRACTr technology is designed to integrate tumor-specific activation with crossover pharmacokinetics to produce best-in-class T cell engager therapeutics. It’s a big bet for Merck.

Immune Response 52

Immune Response Pharmacokinetics Engineering Licensing 52

The Pharma Data

AUGUST 28, 2020

Celltrion has already begun trials of the treatment, called CT-P59, in July following their clinical trial authorisation application from the UK’s Medicines and Healthcare products Regulatory Agency.

Trials 52

Trials Treatment Clinical Trials Pharmacokinetics 52

Alta Sciences

OCTOBER 30, 2023

TOP NONCLINICAL SCIENTIFIC RESOURCES eBook : Safety Assessment for Ophthalmic Products Designing preclinical studies for ocular therapies take a lot of deliberation. Catch up on what you may have missed below! Watch it now. The Altascientist : Issue No.

Science 52

Science Clinical Trials Pharmacokinetics Pharmacy 52

The Pharma Data

JULY 12, 2021

These data include results from a late-breaking presentation from a Phase 2a study evaluating the safety and pharmacokinetics (PK) of once-monthly (QM) oral islatravir for pre-exposure prophylaxis (PrEP) through 24 weeks. Safety and Pharmacokinetics of Islatravir in Study Participants with Severe Renal Insufficiency. Abstract 2361.

Pharmacokinetics 52

Pharmacokinetics Clinical Trials Trials Treatment 52

The Premier Consulting Blog

SEPTEMBER 11, 2024

The 505(b)(2) new drug application (NDA) pathway offers a unique opportunity for small molecule developers to bring innovative products to market more efficiently by leveraging existing data they do not own or have right of reference to. The new formulation resulted in a drug product that was very viscous. Human factors.

Drugs 52

Drugs Clinical Pharmacology Packaging Small Molecule 52

The ChEMBL-og

JUNE 13, 2023

This fresh release comes with a few new data soures and also some new features: we added bioactivity data for understudied SLC targets from the RESOLUTE project and included a flag for Natural Products and for Chemical Probes. An an annotation for the ACTION_TYPE of a measurement was included for approx. 270 K bioactivities.

FDA Approval 97

FDA Approval Pharmacokinetics International Production 97